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Indian drugmakers Posh Chemicals and Promed Exports received warning letters from the U.S. FDA that indicated breaches in good manufacturing practices. Six India-based drug facilities have received the notices in the past three months. Lupin Pharma CEO Vinita Gupta said "all the FDA is trying to do is differentiate the good manufacturers from the not-so-good ones. Indian manufacturers are not being targeted."

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The U.S. FDA is stepping up inspections of drug-industry facilities in India and their compliance with manufacturing standards. The agency is training and enrolling more drugs investigators in the second-biggest supplier of finished dose treatments to the U.S. "Having these additional inspectors in-country will assist the agency in meeting our legislative mandates," U.S. FDA spokesman Christopher C. Kelly said.

Japan's deregulation council is debating whether to increase reimbursement rates for prescription drugs to spur innovation and investment as part of a broader economic reform effort. The pharmaceutical industry strongly supports such increases. "The declining competitiveness of Japan's drug industry can be seen from the growing share of overseas drugs in the Japanese market," said Eiko Tobita of the Japan Research Institute. The country's finance ministry, however, advocates greater use of generics and lower reimbursements for drugs no longer under patent.

Indian drugmakers will increasingly transition research and development resources from generics to niche therapy drugs, a relatively underdeveloped and potentially lucrative market, a Research and Markets report concludes. Wockhardt, Lupin, Dr. Reddy's, Ranbaxy and other companies have taken steps toward niche drugs, analyst Adefemi Adenuga said.

After getting virtually no response to earlier requests, the Drug Controller General of India has demanded that makers of fixed dose combinations who received clearances from state licensing agencies submit their drugs for safety and efficacy approval no later than Aug. 30 or face removal of their products from the market. Earlier, the DCGI ordered state agencies to withdraw licenses from drugmakers that lacked its approval, but the manufacturers received a stay from the Madras High Court.

The U.S. FDA has issued a proposed rule that would allow manufacturers of generic drugs to revise their warning labels independently of any such changes to their counterpart branded drugs. The new rule is an attempt to "create parity" in the responsibilities of brand-name and generic-drug companies, according to the FDA, and to address complicated legal issues regarding generic-labeling requirements.